BACKGROUND: As no clinical randomised studies have previously been performed comparing complications with the Ciaglia Percutaneous Dilatational Tracheostomy Introducer Set (PDT) and conventional surgical tracheostomy (TR), we designed a study with the aim of comparing the efficacy and safety of the two techniques. METHODS:Sixty patients selected for elective tracheostomy were randomised for either PDT (30 patients) or TR (30 patients). All patients had general anaesthesia and were ventilated with 100% oxygen. Furthermore, lidocaine with epinephrine 1% (3-5 ml) was used for local analgesia and to minimise bleeding during the procedure. RESULTS: The median time for insertion of the tracheostomy tube was 11.5 min (range 7-24 min) in the PDT group and 15 min (range 5-47 min) in the TR group (P<0.01). Complications during the procedure were cuff puncture of the endotracheal tube in 5 cases in the PDT group. Minor bleeding was encountered in 6 cases in the PDT group as opposed to 24 cases in the TR group (P<0.01), major bleeding in none versus 2 cases, respectively. In 8 cases in the PDT group, increased resistance to insertion of the tracheostomy tube was met by further dilatation. During the post-tracheostomy period, complications occurred with minor bleeding in 2 cases in the PDT group as opposed to 9 cases in the TR group (P<0.05), and major bleeding was encountered in 1 case in each group. Minor infections were encountered in 3 cases in the PDT group as opposed to 11 cases in the TR group (P<0.01). Major infection was encountered in none versus 8 cases, respectively (P<0.01). CONCLUSION: Our results indicate that the percutaneous dilatational tracheostomy technique performed with the Ciaglia Introducer Set is effective, safe and superior to conventional surgical tracheostomy as immediate complications as well as complications with the tracheostomy tube in situ are fewer and of less severity.
RCT Entities:
BACKGROUND: As no clinical randomised studies have previously been performed comparing complications with the Ciaglia Percutaneous Dilatational Tracheostomy Introducer Set (PDT) and conventional surgical tracheostomy (TR), we designed a study with the aim of comparing the efficacy and safety of the two techniques. METHODS: Sixty patients selected for elective tracheostomy were randomised for either PDT (30 patients) or TR (30 patients). All patients had general anaesthesia and were ventilated with 100% oxygen. Furthermore, lidocaine with epinephrine 1% (3-5 ml) was used for local analgesia and to minimise bleeding during the procedure. RESULTS: The median time for insertion of the tracheostomy tube was 11.5 min (range 7-24 min) in the PDT group and 15 min (range 5-47 min) in the TR group (P<0.01). Complications during the procedure were cuff puncture of the endotracheal tube in 5 cases in the PDT group. Minor bleeding was encountered in 6 cases in the PDT group as opposed to 24 cases in the TR group (P<0.01), major bleeding in none versus 2 cases, respectively. In 8 cases in the PDT group, increased resistance to insertion of the tracheostomy tube was met by further dilatation. During the post-tracheostomy period, complications occurred with minor bleeding in 2 cases in the PDT group as opposed to 9 cases in the TR group (P<0.05), and major bleeding was encountered in 1 case in each group. Minor infections were encountered in 3 cases in the PDT group as opposed to 11 cases in the TR group (P<0.01). Major infection was encountered in none versus 8 cases, respectively (P<0.01). CONCLUSION: Our results indicate that the percutaneous dilatational tracheostomy technique performed with the Ciaglia Introducer Set is effective, safe and superior to conventional surgical tracheostomy as immediate complications as well as complications with the tracheostomy tube in situ are fewer and of less severity.
Authors: David B Seder; Kiwon Lee; Celine Rahman; Nirmala Rossan-Raghunath; Luis Fernandez; Fred Rincon; Jan Claassen; Errol Gordon; Stephan A Mayer; Neeraj Badjatia Journal: Neurocrit Care Date: 2009-01-06 Impact factor: 3.210
Authors: Javier Romero Ganuza; Angel Garcia Forcada; Claudia Gambarrutta; Elena Diez De La Lastra Buigues; Victoria Eugenia Merlo Gonzalez; Fátima Paz Fuentes; Alejandro A Luciani Journal: J Spinal Cord Med Date: 2011 Impact factor: 1.985
Authors: Rosa Klotz; Pascal Probst; Marlene Deininger; Ulla Klaiber; Kathrin Grummich; Markus K Diener; Markus A Weigand; Markus W Büchler; Phillip Knebel Journal: Langenbecks Arch Surg Date: 2017-12-27 Impact factor: 3.445